Process Validation of Ursodeoxycholic Acid Tablet Ip 300 Mg.

Abstract

Introduction: Process validation is a critical aspect of current Good Manufacturing Practices (cGMP) ensuring consistent production of pharmaceutical products meeting predetermined quality criteria. This study presents the prospective process validation of Ursodeoxycholic Acid (UDCA) Tablets 300 mg using three consecutive commercial-scale batches. The manufacturing process involved wet granulation, compression, and film coating, and was evaluated for critical process parameters (CPPs) and critical quality attributes (CQAs).All three batches conformed to quality specifications, confirming process consistency and robustness. This paper emphasizes the importance of a structured validation approach in guaranteeing product quality, safety, and efficacy.

Objectives: . The primary objective of validation is to ensure consistent product quality throughout the entire production lifecycle. It serves as a vital component of quality management systems, guiding manufacturers to meet regulatory expectations related to process validation.

Methods: All analytical methods (assay, dissolution, impurities) were validated according to ICH Q2 (R1). Standards traceable to Pharmacopeial reference materials were used. Data were recorded in Validation Batch Records and compared to predetermined targets.

Results: The samples were collected and tested as per sampling protocols .The observations made during each critical step which are discussed in our research work which are given in detail.

Conclusions: The manufacturing process for Ursodeoxycholic Acid Tablets 300 mg was successfully validated using a prospective approach. . All three validation batches consistently met the predefined critical quality attributes (CQAs) and regulatory  specifications, confirming the process is robust, reproducible, and suitable for routine commercial manufacturing.